CDSCO panel approves Allergan Dexamethasone Intravitreal Implant for Diabetic Macular Edema

New Delhi: Based on the justification provided by the drug-maker Allergan India, the Subject Expert Committee (SEC) functional under Central Drug Standard Control Organization (CDSCO) has given its nod for the additional indication for Dexamethasone Intravitreal Implant 0.7mg for the treatment of Diabetic Macular Edema(DME).

However, this approval is subjected to the condition that the firm should conduct active Post-marketing Surveillance (PMS) study in 500 patients with follow-up period of six months.
This came in line with the proposal presented by the drug maker Allergan India for the additional indication of Dexamethasone Intravitreal Implant 0.7mg “for the treatment of diabetic macular edema”.

Diabetic macular edema (DME) is the accumulation of excess fluid in the extracellular space within the retina in the macular area, typically in the inner nuclear, outer plexiform, Henle’s fiber layer, and subretinal space.

Dexamethasone intravitreal implant is a steroid injected into the eye that is used to treat swelling that may occur when there is a blockage of blood vessels in the eyes. It is also used to treat non-infectious uveitis affecting the posterior segment of the eye. It is mainly indicated for the treatment of macular edema following branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO). It is particularly indicated for the treatment of diabetic macular edema.

This intravitreal injection procedure is carried out under controlled aseptic conditions. These conditions include the use of sterile gloves, a sterile drape, and a sterile eyelid speculum or any other equivalent. Adequate anesthesia and a broad-spectrum microbicide applied to the periocular skin, eyelid, and ocular surface are recommended to be given prior to the injection. The patients are monitored for elevation in intraocular pressure and for endophthalmitis, following the injection.

At the recent SEC meeting for Ophthalmology held on 26th May 2022, the expert panel reviewed the proposal of Dexamethasone Intravitreal Implant 0.7mg for the treatment of diabetic macular edema.

In addition, the committee noted that the proposed indication is approved by USFDA.
After detailed deliberation, the committee recommended approval of the additional indication “for the treatment of diabetic macular edema” with the condition to conduct an active PMS study in 500 patients with a follow-up period of six months.
Accordingly, the protocol should be submitted within three months of approval of the drug allergen India.

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